Thu, Aug. 4, 4:40 PM
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Tue, Jul. 5, 10:24 AM
- The FDA has designated Five Prime Therapeutics' (FPRX +0.9%) FPA144 an Orphan Drug for the treatment of gastric cancer, including cancer of the gastroesophageal junction, in patients with tumors that overexpress a protein called FGFR2b, an oncogene that is present in up to 35% of gastric cancer cases that is associated with aggressive disease.
- Phase 1-stage FPA144 is a humanized monoclonal antibody that binds to FGFR2b.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
Fri, Jun. 3, 12:47 PM
Thu, May 5, 4:28 PM
Wed, May 4, 5:35 PM
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Sat, Apr. 2, 5:10 PM
Thu, Mar. 10, 4:26 PM
- Five Prime Therapeutics (NASDAQ:FPRX): Q4 EPS of $10.63 beats by $0.96.
- Revenue of $363.3M beats by $9.14M.
- Shares +2.5% AH.
Wed, Mar. 9, 5:35 PM
Wed, Jan. 20, 5:06 PM
- The U.S. Attorney's for the Eastern District of Pennsylvania issues an indictment charging five people in an alleged scheme to steal trade secrets from GlaxoSmithKline (NYSE:GSK). The five, Yu Xue, Tao Li, Yan Mei, Tian Xue and Lucy Xi, are charged with conspiracy to steal trade secrets, conspiracy to commit wire fraud, conspiracy to commit money laundering, theft of trade secrets and wire fraud.
- Two of the five, Yu Xue and Lucy Xi, were scientists working at a Glaxo research facility in Upper Merion, PA when they allegedly stole GSK trade secrets related to research data, procedures and manufacturing processes for biopharmaceutical products, many in the cancer space. Apparently, Yu Xue, Tao Li and Yan Mei formed a corporation in China, called Renopharma, under which they intended to monetize the stolen information. The indictment further alleges these three individuals attempted to cover their tracks by agreeing to title the proceeds in the name of Yu Xue's sister, Tian Xue.
- In a regulatory filing, Five Prime Therapeutics (NASDAQ:FPRX) disclosed that Glaxo informed it of the matter yesterday because the pilfered data included information related to FP-1039, its ligand trap candidate being developed with Glaxo. It does not yet know if the situation will negatively impact the company or FP-1039.
Tue, Jan. 19, 11:48 AM
Nov. 4, 2015, 4:26 PM
- Five Prime Therapeutics (NASDAQ:FPRX): Q3 EPS of -$0.93 beats by $0.06.
- Revenue of $5.9B (+97259.7% Y/Y) beats by $5.9B.
Nov. 3, 2015, 5:35 PM
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Oct. 15, 2015, 12:46 PM
Oct. 15, 2015, 9:13 AM
Oct. 15, 2015, 7:44 AM
- Bristol-Myers Squibb (NYSE:BMY) goes all in with Five Prime Therapeutics (NASDAQ:FPRX) in a license and collaboration deal worth up to $1.74B. The partnership will focus on the development of Five Prime's colony stimulating factor 1 receptor (CSF1R) antibody program, including FPA008, in combination with Opdivo (nivolumab) and other therapies. The new agreement replaces the companies' existing collaboration to evaluate Opdivo with FPA008 in six tumor types.
- Under the terms of the agreement, Five Prime will receive an upfront payment of $350M, up to $1.05B in development and regulatory milestones for CSF1R oncology indications (including combinations with Opdivo and any other agent), up to $340M in development and regulatory milestones for CSF1R non-oncology indications and double-digit royalties on commercial sales (higher if Five Prime elects to co-promote in the U.S.).
- FP008 is an investigational antibody that inhibits CSF1R. It targets certain immune cells called macrophages and monocytes that are elevated/activated in multiple disease settings. These cells secrete a variety of proteins that attract and activate inflammatory cells. Derivatives of these inflammatory cells directly destroy bone tissue in joints. Tumor-associated macrophages (TAMs) are elevated in many tumor types and are believed to be involved in suppressing the immune response to the cancer cells. It is being developed for the potential treatment of a range of cancers, pigmented villonodular synovitis (inflamed and swollen joints) and rheumatoid arthritis.
- FPRX, up 62% premarket, will host a conference call this morning at 8:30 am ET to discuss the deal.